Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2 CYP2C9 CYP2C19 and CYP3A4

  • STATUS
    Not Recruiting
  • End date
    Oct 9, 2022
  • participants needed
    15
  • sponsor
    R-Pharm International, LLC
Updated on 2 June 2022
body mass index
methotrexate
hydroxychloroquine
folic acid
folate
sulfasalazine
rheumatism

Summary

Olokizumab (OKZ) has been shown to reverse the inhibitory effect of IL-6 on the activity of Cytochrome P450 (CYP450) isozymes CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A4/5 in vitro.

The goal of the study is to assess the effect of OKZ on the pharmacokinetics (PK) of the CYP450 probe substrates, caffeine (CYP1A2), S-warfarin (CYP2C9), omeprazole (CYP2C19), and midazolam (CYP3A4) in subjects with rheumatoid arthritis (RA).

Description

This is a Phase 1, open-label, 3-period, single-sequence, crossover study in subjects with RA with increased C-reactive protein (CRP).

Approximately 15 eligible subjects will be enrolled at approximately 3 study centers to have at least 12 evaluable subjects completing the study. However, if necessary, additional subjects may be dosed to obtain the 12 evaluable subjects required.

There will be a 35-day Screening Period, followed by a 29-day study duration: eligible patients will be administered a cocktail of 4 substrates alone during 7-day PK-sampling (Period 1); a single subcutaneous dose of 128 mg OKZ will be administered (Period 2) approximately 2 weeks prior to the second administration of the cocktail in 7-day PK-sampling (Period 3). After completion of the Period 3 patients will be followed-up for 19 weeks (133 days) for safety evaluations.

Overall duration of the study will be approximately 200 days (6 and a half months).

Details
Condition Rheumatoid Arthritis, Rheumatoid Arthritis (Pediatric)
Treatment Midazolam, caffeine, Omeprazole, Olokizumab, Warfarin+ Vitamin K
Clinical Study IdentifierNCT04246762
SponsorR-Pharm International, LLC
Last Modified on2 June 2022

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